510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981937Substantially Equivalent

Welch Allyn Reveal Intraoral Camera System

Welch Allyn Inc, Skaneateles Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981937 is the FDA 510(k) clearance record for WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM, a class I device, cleared for Welch Allyn, Inc. on under FDA product code EIA (Unit, Operative Dental). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K981937.

Clearance record

Decision date
Received
(83 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Welch Allyn, Inc. 4619 Jordan Rd., Skaneateles Falls NY
510(k) summary
Summary
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20261
November 20260